This invention relates to methods of identifying specialty drugs, to methods of creating tools to be used in identifying specialty drugs, and to tools used in the identification of specialty drugs.
Pharmacy benefit managers (“PBMs”) administer drug benefit programs for employers, managed care organizations, third-party health plan administrators, purchasing coalitions, and other groups who provide and/or offer health care benefits to a group of individuals. Historically, PBMs were involved primarily in processing or adjudicating claims for reimbursement for purchases of pharmaceuticals. More recently, PBMs have become involved in broader aspects of patient care.
To that end, many PBMs have developed and/or acquired “specialty pharmacies.” A specialty pharmacy has been variously described as: a pharmacy, the services of which are used by patients with acute or chronic conditions that can be treated at home, in a physician's office, or at specialized infusion sites (e.g., Walgreen's); a company that works with customers to manage use of high-cost drugs used to treat chronic diseases (e.g., Magellan Health Services); a pharmacy that provides “full-service care to patients requiring special prescription needs for challenging and long-term health conditions” (e.g., CVS, describing Stadtlander in its acquisition of that company); and a provider of pharmacy services for people with complex chronic health conditions (e.g., BioScrip, describing Chronimed Inc.). A principal theme in these descriptions is that there is something special in the level of care provided and/or the type of pharmaceutical involved in the care.
Drugs provided by a specialty pharmacy or otherwise designated as “specialty pharmaceuticals” or “specialty drugs” may be subject to pricing guidelines that are different than for other drugs covered under a health plan. For example, a non-specialty drug might be priced by a PBM to its client at a benchmark price less a percentage A, whereas a specialty drug might be priced at a benchmark price less a percentage B. Furthermore, specialty drugs (which, in some cases are administered by a physician at his or her office) may be provided as part of a patient's medical benefit, as opposed to the patient's pharmaceutical benefit. In addition, a drug dispensed as a specialty drug may be provided with a higher level of care and/or patients who receive specialty drugs may be afforded access to resources not available for patients who receive non-specialty drugs. Because of these distinctions, whether a drug is a specialty drug is often important to PBMs, customers of PBMs, and/or to the patients covered by drug benefit programs managed by PBMs. As indicated below, the significance of whether a drug is a specialty drug is far-reaching.
Historically, classification of a drug as a “specialty drug” has been quite subjective. One definition of “specialty drug” encompassing various criteria that have been used for classification of a drug as a specialty drug might be “an injectable, infused, oral, or inhaled drug having one or more of the following characteristics: (1) a requirement for frequent dosing adjustments and intensive clinical monitoring to decrease the potential for drug toxicity and increase the probability for beneficial treatment outcomes; (2) a need for intensive patient training and compliance assistance to facilitate therapeutic goals; (3) limited or exclusive availability and distribution; (4) specialized handling and/or administration requirements; and (5) cost in excess of $500 for a 30-day supply.” CuraScript, Inc., 2004 Specialty Pharmacy Management Guide & Trend Report (June, 2005). Such a definition may make it difficult to explain to a customer or plan participant why one particular drug is classified as a specialty drug but another is not. That in turn makes medical care cost decisions less transparent and comprehensible and tends to harm a PBM's relationship with its customers and the plan participants.
Because classification of a drug as a “specialty drug” may affect, among other things, (1) pricing of the drug, (2) determination of whether the drug is provided as part of a prescription benefit or medical benefit, and/or (3) the level of care and/or services provided in connection with sale, dispensing, administration, distribution, and/or monitoring of the drug and/or its apparent effectiveness, whether or not a drug is classified as a “specialty drug” may be quite important.
Thus, there is a need for a method of identifying specialty drugs that ideally: (1) is more objective than current methods, (2) is more transparent than current methods and/or is capable of being understood more readily than current methods, e.g., by a customer of a PBM and/or a participant in a pharmacy benefit plan administered by a PBM, (3) produces relatively consistent determinations of whether or not a drug is a specialty drug when the method is employed by different users, and (4) is easily implemented to (a) identify a set of specialty drugs, (b) evaluate newly-approved drugs for their specialty drug status, and (c) re-evaluate drugs for their specialty drug status with changing circumstances.